Products | UK Regulatory Outlook October 2025

Jump to: Product sustainability | Life Sciences and Health

General and Digital 

UK 

Amazon marketplace liability under spotlight: admission and settlement in UK injury case 

The High Court claim brought by a consumer injured while using a power tool bought from Amazon in 2022 (and subsequently flagged by the Office for Product Safety and Standards as a serious risk in 2023) has now been settled. Amazon admitted full liability without advancing a defence and the matter settled for an undisclosed five-figure sum.  

The claim was brought under the Consumer Protection Act 1987 (CPA), alleging that the saw in question was defective, and in contract, alleging that it was not of satisfactory quality and/or fit for purpose. Specifically, the claimant alleged that Amazon was liable under the CPA on the basis that it held itself out as producer of the product, was its importer into the UK, or was the supplier into the UK.  

The claim is said to be the "first of its kind" and will be of particular interest given the Law Commission is currently reviewing the UK's product liability regime, as reported in last month's issue.  

Tobacco and vapes: call for evidence to inform future UK legislation 

The Department of Health and Social Care (DHSC) has opened an evidence call to support policy development on tobacco, vapes and nicotine products. The evidence call comes as the Tobacco and Vapes Bill is being considered by Parliament. Areas of interest include flavouring substances, permitted nicotine levels, device sizes and technology, and proposals for retail licensing and product registration schemes in order to sell the products.  

The DHSC is inviting input from manufacturers, retailers, enforcement bodies and health organisations on proportional models for licensing and registration and on effective compliance and sanctions. Evidence on youth appeal (including flavour descriptors, packaging and device design) is specifically sought to inform future restrictions. 

The call for evidence closes on 3 December 2025. 

Businesses operating in this sector should review the call for evidence and consider whether they wish to submit their views.  

EU 

European Commission publishes work programme 2026 

On 21 October 2025, the European Commission published the Commission work programme 2026 setting out its main plans and priorities for 2026. There is a continued focus on simplification initiatives and omnibus packages with the aim of reducing administrative burdens by 25% with the report highlighting the following key changes: 

• European Product Act, scheduled for Q3 of 2026: new legislative framework of product rules; update the rules of market surveillance and compliance of products; and update to the rules on standardisation.
• Circular Economy Act, scheduled for Q3 of 2026, to foster demand and supply of circular products, reduce dependencies on critical resources and continue to speed up implementation and investment under the Clean Industrial Deal.
• Critical Raw Materials Centre, scheduled for Q2 of 2026, to monitor, jointly purchase and stockpile critical raw materials which are essential to industrial sovereignty.
• Cloud and AI Development Act, scheduled for Q1 of 2026, to strengthen technological leadership of industry and European strategic autonomy.
• Evaluation of the Cosmetic Products Regulation, scheduled for Q4 of 2026.
• Evaluation of the European Food Safety Authority, scheduled for Q2 of 2026. 

Limited details on these changes are currently available and more information will be released throughout the year. Please see the ESG section for updates on the progress of the current omnibus packages. 

MEPs push for new legislative framework that supports the digital and green transition 

On 25 September 2025, the Internal Market Committee adopted a report proposing revision to the EU's new legislative framework (NLF) for products, to support the digital and sustainable transition. The report calls for harmonised definitions and certification for refurbishers and repairers and places an emphasis on promoting sustainable business models and consumption patterns. 

Of particular interest is the call for new EU product laws to align with other EU initiatives, such as ecodesign, the right to repair and the Waste Framework Directive. Consequently, for example, under the NLF manufacturers should be required to ensure the availability of spare parts and maintenance services over an extended period in line with the Right to Repair Directive. The MEPs also call on the Commission to address the risks and challenges associated with fast and ultra-fast fashion business models – in line with the Waste Framework Directive. 

The proposed revisions also suggest that the Digital Product Passport (DPP) should be gradually introduced for all relevant products, including second hand items. It should also replace existing declarations of conformity and be used to integrate CE marking information. 

Council adopts new EU Toy Safety regulation 

On 13 October 2025, the Council of the EU gave its final approval, and formal adoption of the toy safety regulation, repealing Directive 2009/48/EC. The Commission proposed this regulation on 28 July 2023 to update the safety requirements for toys placed on the EU market, whether manufactured in the EU or elsewhere. 

The new regulation is in line with the EU chemicals strategy for sustainability that called for strengthening the protection of consumers and vulnerable groups from the most harmful chemicals. Substantively, the new regulation will ban or restrict the use of certain harmful chemical substances in toys, including endocrine disruptors, skin sensitisers, biocidal products, and per- and polyfluoroalkyl substances (PFAS). It will also introduce DPPs for toys to facilitate customs control and market surveillance of toys on the EU market. 

The European Parliament is expected to formally adopt the regulation at second reading at its plenary session on 24 November 2025. The Act will then be published in the Official Journal of the European Union and enter into force 20 days after publication. It will start to apply 4.5 years from that date. UK traders selling to toys into the EU market will also need to consider the regulation. 

Product sustainability 

EU 

Waste Framework Directive: amending directive introduces EPR scheme for textiles 

Following its adoption by the European Parliament and Council, on 26 September 2025, Directive (EU) 2025/1892 amending the Waste Framework Directive 2008/98/EC was published in the Official Journal of the European Union and came into force on 16 October 2025. 

As previously reported, the amending directive introduces an extended producer responsibility (EPR) scheme for textiles. Producers that make textiles available in the EU will have to cover the costs of their collection, sorting and recycling through new EPR schemes to be set up by each Member State by 16 April 2028 (within 30 months of the amending directive's entry into force on 16 October 2025). The provisions will apply to all producers, including those using e-commerce tools, whether they are established in an EU Member State or outside the EU. Micro-enterprises will have an extra year to comply with the EPR requirements. 

The EPR requirements cover textile products such as clothing and accessories, hats, footwear, blankets, bed and kitchen linen, and curtains. Member States are required to establish a register of producers of such products to monitor compliance. 

Commission presents mandatory guarantee notice and voluntary durability label  

On 25 September 2025, the European Commission announced that it had adopted an implementing regulation which specifies the form and content of the new harmonised notice and label introduced by the Empowering Consumers for the Green Transition Directive ((EU) 2024/825). This follows an earlier consultation on the mandatory notice and label launched in June 2025. 

The harmonised notice is mandatory, must be prominently displayed in all EU retail outlets (both online and offline), and provides information about the minimum two-year legal guarantee of conformity for goods. Sellers are obliged to provide repair and replacement at no cost, where the goods do not function as intended, with price reduction or full reimbursement available in some cases. The notice should include a QR code that directs consumers to more detailed information on their rights under Union law provided by the legal guarantee of conformity. The QR code should provide access to Member States’ portals. 

The harmonised label is voluntary for products that fall under any free commercial durability guarantee that lasts longer than the two-year minimum period required by EU law and that covers the entire product. The label must be prominently displayed, whether the product is being sold online or offline, so that consumers can identify which products benefit from the guarantee. The label must have a language-neutral, easily reproducible design combining the “GARAN” title (referencing “guarantee” in several EU languages), a tick mark indicating guaranteed durability, a calendar showing the guarantee’s duration, and a visual reminder of the legal guarantee of conformity. The label also should include a QR code which directs consumers to more detailed information given the limited space on the label. 

Online, both the notice and label must be in colour. Offline, colour or black and white is permitted and for distance contracts via an online interface, the label may be shown in a nested format. 

The notice and label form part of the implementation of the Empowering Consumers for the Green Transition Directive ((EU) 2024/825), which Member States have until 27 March 2026 to transpose into national law, and then must apply by 27 September 2026. UK traders selling to EU residents will also need to consider the notice and label from September 2026. 

European Commission proposes delay to EU Deforestation Regulation despite industry opposition 

Please see ESG. 

Simplification to the EU CBAM enters into force 

Please see ESG. 

Life Sciences and Health 

UK 

MHRA updates guidance on clinical trials in the UK 

On 1 October 2025, the Medicines and Healthcare products Regulatory Agency (MHRA) updated its clinical trial guidance in anticipation of the Medicines for Human Use (Clinical Trials) (Amendment) Regulations 2025 which significantly amends the Medicines for Human Use (Clinical Trials) Regulations 2004, and will take effect from 28 April 2026. The key updates include: 

• changes to the approval pathway;
• changes to notifiable trials;
• new documents on Route A and B for modifying a clinical trial approval;
• a new page of guidance dedicated to clinical trials that include an in vitro diagnostic device; and
• clarification on transitional arrangements. 

Currently, parts of the guidance are in draft and, according to the MHRA, "should only be used to support sponsors in preparing for the implementation of the new regulations." 

MHRA advances AI Airlock Phase 2 

Earlier this year, the UK government confirmed that the MHRA’s AI Airlock will run a second phase in the 2025–2026 financial year, following the pilot programme that closed in April 2025.  

The AI Airlock is the MHRA’s first regulatory sandbox for AI as a Medical Device, designed to use real-world products to explore and resolve regulatory challenges. 

On 16 October, the government published guidance on Phase 2. It will include seven additional technologies spanning AI-powered clinical note taking, advanced cancer diagnostics, eye disease detection tools, and obesity treatment support systems. This expansion is structured around three core regulatory challenge areas (managing evolving AI applications, regulating AI-powered diagnostics effectively and implementing robust post‑market surveillance) using both multi‑environment and simulation candidates.  

Applications for Phase 2 have closed and candidates will test in the airlock until March 2026, when the second phase will be finalised. Read the pilot programme report.  

Insights from the pilot and Phase 2 will inform recommendations to the MHRA’s National Commission into the Regulation of AI in Healthcare and shape future MHRA guidance and policy.  

AI medical device developers and NHS providers should monitor Phase 2 outputs and forthcoming updates.  

CMA proposes major reforms to UK veterinary services market 

The Competition and Markets Authority (CMA) published on 15 October its vets provisional decision in its market investigation into the UK's £6.3 billion veterinary services market, proposing 21 major reforms designed to transform the consumer experience and increase competition. The investigation identified several concerns, including that pet owners often lack awareness of prices for commonly used services and of whether their local practices are part of large national chains, and they may be paying twice as much for commonly prescribed medicines from vet practices than they could pay online. Average vet prices across the market rose by 63% between 2016 and 2023 – well above the rate of inflation – and the CMA found that pet owners pay 16.6% more on average at large vet groups than at independent vets. 

The proposed changes include requiring vet businesses to publish comprehensive price lists, capping prescription fees at £16, automatically providing written prescriptions for frequently needed medicines and mandating written estimates for treatments over £500. The CMA also found that the current regulatory system is not fit for purpose, as it only regulates individual veterinary professionals and not vet businesses, despite the majority of practices being part of large corporate groups. Consequently, the CMA has recommended that the government urgently prioritises a new Veterinary Surgeons Act to replace the existing 1966 legislation and updates regulation to include veterinary businesses.  

Following a public consultation closing on 12 November, the CMA's final decision will be published by March 2026, with some measures potentially coming into force before the end of 2026. 

EU 

Council adopts conclusions on EU life sciences competitiveness strategy 

On 30 September 2025, the Council of the EU adopted a comprehensive strategy to strengthen the life sciences and biotechnology sectors across Member States. In adopting the strategy, the Council recognised the sector’s potential to contribute to "advancing fundamental knowledge and driving innovation in strategically important areas such as healthcare, medical technologies and pharma, agriculture, bioeconomy, terrestrial and aquatic food systems, biotechnology, biodiversity and environmental sciences." 

The conclusions call for coordinated action to enhance research and innovation, improve regulatory coherence and support ethical and societal dialogue to attempt to make the EU the world's most attractive place for life sciences by 2030. At the same time, it underlines the importance of a business-friendly regulatory framework, that reduces administrative burden and supports innovative SMEs and sustainable manufacturing capacities. 

Key areas identified for intervention include healthcare, agriculture, industrial processes and environmental protection, with emphasis on biosafety, consumer choice and international cooperation. Cooperation between Member States and the EU Commission will also be critical to build and connect research infrastructure and build technological leadership.